Clinical trial · Interventional
Comparison of AMR and ADR Between Endocuff Vision-assisted and Conventional Colonoscopy: a Multicenter Randomized Trial
Comparison of Adenoma Miss Rate and Adenoma Detection Rate Between Endocuff Vision®-Assisted Colonoscopy and Conventional Colonoscopy: a Multicenter Randomized Trial
NCT03418948CI-TRIAL-00031502EXCEEDunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this international multicenter study is to compare the adenoma detection rate and adenoma miss rate of conventional and Endocuff Vision-assisted colonoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2x CC | Device | — | UNRESOLVED |
| 2x EC | Device | — | UNRESOLVED |
| CC followed by EC | Device | — | UNRESOLVED |
| EC followed by CC | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 2 x CC
- description
- 2 x conventional colonoscopy (CC), back-to-back design
- interventionNames
- Device: 2x CC
- type
- ACTIVE_COMPARATOR
- label
- CC followed by EC
- description
- Conventional colonoscopy followed by Endocuff Vision- assisted colonoscopy, back-to-back design
- interventionNames
- Device: CC followed by EC
- type
- ACTIVE_COMPARATOR
- label
- EC followed by CC
- description
- Endocuff Vision-assisted colonoscopy followed by conventional colonoscopy, back-to-back design
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients, aged between 40 and 75-years old, referred and scheduled for either screening (non-FIT/gFOBT based), diagnostic or surveillance colonoscopy. Exclusion Criteria: * Prior surgical resection of any portion of the colon or a history of radiotherapy for any abdominal or pelvic disease. * Personal history of colon cancer or polyposis syndrome. * Familial adenomatous polyposis (FAP) * Known colitis or suspicion of colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis). * Lower gastro-intestinal bleeding requiring acute intervention. * Suspicion of large bowel obstruction or toxic megacolon. * Prior incomplete colonoscopy (not including insufficient preparation). * Patients referred for a therapeutic procedure or assessment of a known non-resected lesion. * Not sufficiently corrected anticoagulation disorders * Poor general condition (\>3 American Society of Anesthesiologist) * Overweight (\>120 kg) * Inability to provide informed consent.
References
Publications (1)
- DERIVEDvan Keulen KE, Papanikolaou IS, Mak TWC, Apostolopoulos P, Neumann H, Delconte G, Furnari M, Peters Y, Lau JYW, Polymeros D, Schrauwen RWN, Cavalcoli F, Koukoulioti E, Triantafyllou K, Anderson JC, Pohl H, Rex DK, Siersema PD. Comparison of adenoma miss rate and adenoma detection rate between conventional colonoscopy and colonoscopy with second-generation distal attachment cuff: a multicenter, randomized, back-to-back trial. Gastrointest Endosc. 2024 May;99(5):798-808.e3. doi: 10.1016/j.gie.2023.11.017. Epub 2023 Nov 20. PMID 37993062